DIA 2018 Global Annual Meeting has ended

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DIA 2018 Global Annual Meeting

8:00am EDT

Registration for Full Day and Morning Preconference Short Courses North Lobby Exhibitor Registration North Lobby

8:30am EDT

#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know? Room 157C #21: The IDMP Challenge: Points to Consider for Pharmacovigilance Departments Room 158 #22: Protocol Co-Design with Patients and Advocates Room 159 #23: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle Room 160A #24: Preparing for a US FDA Advisory Committee Meeting Room 160B #25: Precedent: A Driver of Regulatory Strategy Room 160C #27: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment Room 161 #28: Preparing Documents for Disclosure and Public Sharing Room 162A #29: Leadership: How to Organize and Lead People in a Work Group Room 162B

9:00am EDT

#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm Room 253C #42: Back to the Future: Combination Products in the 21st Century Room 256

10:30am EDT

#000: Emerging Professionals and Student Forum Commonwealth Room Westin

12:30pm EDT

Registration for Afternoon Preconference Short Courses, Conference Attendees, and Speakers North Lobby

1:00pm EDT

#30: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model Room 160A #31: Machine Learning in Pharmacovigilance Room 160B #33: Quality Tolerance Limits/Issue Management: Taming the Beast of Clinical Development Risk Room 161 #34: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development Room 159 #35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban Room 162A #36: Value Pricing Bootcamp: A Crash Course in How to Use Real World Evidence to Better Measure Outcomes and Evaluate New Innovative Therapies Room 162B #37: Data Visualization in the Life Sciences Room 160C

3:00pm EDT

#001: Effective Use of Social Media Room 252AB

4:15pm EDT

#002: The Power of Networking Room 252AB

7:00am EDT

Attendee, Speaker, and Exhibitor Registration North Lobby

7:30am EDT

Annual Meeting Orientation Room 252AB Coffee and Light Refreshments North Lobby

8:30am EDT

#100: Opening Plenary Session and Keynote Speaker Ballroom

10:00am EDT

Coffee Break Exhibit Hall Exhibit Hall Open Exhibit Hall Student Poster Session Posters Exhibit Hall

10:15am EDT

#101: PAREXEL International Innovation Theater: Innovation’s Greater Purpose - How Technology Can Increase Commercial Success Theater 1 Exhibit Hall #102: Deloitte Innovation Theater: Engage. Innovate. Execute. - How Digital Technologies are Transforming Clinical Development Theater 2 Exhibit Hall #103: Networking Do's and Don'ts E and E Exhibit Hall

10:30am EDT

#104: LinkedIn Review Content Hub NE Lobby

11:00am EDT

#105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model Room 253AB #107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials Room 257AB #108: From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design Room 258AB #111: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity Room 209 #115: Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval Room 156ABC #117: Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D Room 205C #122: Contracting for Value: From Outcomes-Based Contracts to Bundled Payment Programs: What’s Working and Why Room 252AB #106: Signal Management: Separating Needles From Haystacks Room 253C #109: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials Room 258C #110: Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research Room 208 #112: Scientific Communication Key Message Development, Management, and Dissemination Room 210C #113: Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success? Room 151AB #114: A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases Room 153ABC #116: Culture: The Link Between Team Culture and Productivity - An Interactive Workshop Room 254AB #118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making? Room 205AB #119: ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017 Room 204AB #120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection Room 206AB #121: Use of Historical Information in Clinical Trial Design Room 256 #123: Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge Room 157AB #124: Analyzing Innovations Progress in the Gottlieb Era Room 210AB

12:00pm EDT

Luncheon Service Exhibit Hall

12:30pm EDT

#126: EU Global Data Protection Regulation and Impact on US Companies Content Hub NE Lobby #125: Organizational Change and Knowledge Management for Cybersecurity Threats E and E Exhibit Hall

12:45pm EDT

#127: IQVIA Innovation Theater: Re-imagine Clinical Development with Human Data Science Theater 1 Exhibit Hall #128: PPD Innovation Theater: Reimagining Study Planning and Feasibility to Create More Efficient Clinical Trials Theater 2 Exhibit Hall

1:15pm EDT

#129: Using Quality-Inspired Dashboards to Track Patient Engagement Content Hub NE Lobby

1:30pm EDT

#130: PAREXEL International Innovation Theater: The Innovation Imperative: The Future of Drug Development Theater 1 Exhibit Hall #131: Covance Innovation Theater: Evidence-Based Approaches to Accelerating Patient Recruitment and Improving Patient Retention Theater 2 Exhibit Hall

1:45pm EDT

#132: New Approaches, Novel Endpoints, and Next-Generation Trials E and E Exhibit Hall #133: DIA Good Clinical Practices and QA Community Round Table Discussion: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity Community Zone NE Lobby #134: DIA Medical Writing Community Round Table Discussion: Scientific Communication Key Message Development, Management, and Dissemination Community Zone NE Lobby

2:00pm EDT

#135: On the Soapbox: Right to Try Room 157AB #136: Drug Safety: A Continuum Approach Linking Pre-Market and Post-Market Safety Assessment Content Hub NE Lobby

2:15pm EDT

#137: DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation - ‘Wide-Angle-Data’ - Intuitive Algorithms and Artificial Intelligence for Real-time Safety and Risk Management Theater 1 Exhibit Hall #138: SAS Institute Innovation Theater: Real World Evidence - Better, Faster, More! Theater 2 Exhibit Hall

3:00pm EDT

#141: eSource: The Road to Real World Evidence – Are We There Yet? Room 257AB #147: Facilitating Nonclinical Data-Sharing and Access Across the Industry Room 151AB #148: Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific Room 258C #152: FDA Expectations for Demonstration of Interchangeability Room 206AB #139: Novel Approaches to Pharmacovigilance Collaboration Room 253C #140: How Inspection-Ready is Your Organization? Room 253AB #142: Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes Room 258AB #143: Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Stakeholders Room 209 #144: The Evolving Biosimilars Landscape: A Medical Affairs Perspective Room 210C #145: A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors Room 153ABC #146: Development of Microbiome-Derived Therapeutics Room 156ABC #149: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative Room 205C #150: TFDA Town Hall Room 208 #151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future Room 205AB #153: New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges Room 204AB #154: Bayesian Application in Small-Sized Clinical Trials Room 256 #155: Real World Evidence for Value and Access Room 252AB #157: Courageous Leadership Room 254AB #156: International Regulatory Convergence Room 210AB

4:30pm EDT

Opening Reception Exhibit Hall Opening Reception Exhibit Hall

4:45pm EDT

#158: Advanced Clinical Innovation Theater: Preparing for the Next Generation of Clinical Research Theater 1 Exhibit Hall #159: ArisGlobal Innovation Theater: A Clinical Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory Theater 2 Exhibit Hall

5:30pm EDT

#160: Cognizant Innovation Theater - Powering New Possibilities for Site-Sponsor Collaboration with the Shared Investigator Platform in partnership with TransCelerate Theater 1 Exhibit Hall #161: Appian Innovation Theater: Moving beyond Cloud with Digital Transformation to Unify Process, Connect Data, and Turbocharge Innovation Theater 2 Exhibit Hall

7:00am EDT

Coffee and Light Refreshments North Lobby Attendee, Speaker, and Exhibitor Registration North Lobby

8:00am EDT

#202: Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality Room 257AB #203: Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials Room 258AB #207: Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges Room 156ABC #209: Oversight in the Era of E6 (R2) Room 205C #201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin Room 253AB #204: FDA Data Standards Update Room 209 #205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients Room 210C #206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making Room 151AB #208: Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry Room 153ABC #210: Artificial Intelligence: The Future of Regulatory Affairs Room 206AB #211: Update on Collaboration and Trends in Global Companion Diagnostics Room 208 #212: Global Regulatory Strategies for Biosimilars Room 204AB #213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry Room 205AB #214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs Room 253C #215: Pediatric and Rare Disease Drug Development Room 256 #216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome? Room 258C #218: Building Your Brand Room 254AB #217: Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence Room 210AB

9:00am EDT

Coffee Break Exhibit Hall Professional Poster Session 1 Posters Exhibit Hall Exhibit Hall Open Exhibit Hall

9:15am EDT

#219: FDA Warning Letters on Data Integrity Content Hub NE Lobby

9:30am EDT

#220: Brexit: Practical Real-World Solution Planning E and E Exhibit Hall #221: DIA Regulatory Community Round Table Discussion: Artificial Intelligence: The Future of Regulatory Affairs Community Zone NE Lobby #222: DIA Patient Engagement Community Round Table Discussion: New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors Community Zone NE Lobby

9:45am EDT

#223A: On the Soapbox: Blockchain and Genomics Room 157AB #223B: Covance Innovation Theater: Case Study - Driving Clinical Transformation Through a Next-Generation of Data Integration and Analytic Technologies with a GlaxoSmithKline-Covance Partnership Theater 1 Exhibit Hall #224: Veeva Systems Innovation Theater: Global Industry Report - New Findings from the 2018 Unified Clinical Operations Survey Theater 2 Exhibit Hall

10:00am EDT

#225: Building a Dynamic Presentation: Rethinking Audience Engagement Content Hub NE Lobby

10:30am EDT

#228: Global Clinical Trials: Lessons in Effective Execution Room 258AB #231: Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation Room 209 #236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat? Room 205C #237: Expanded Access: Where Are We Now? Room 206AB #226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities Room 253AB #227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible Room 257AB #229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments Room 258C #230: Common Data Model Harmonization for Evidence Generation Room 208 #232: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications Room 210C #233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives Room 151AB #234: Personalized Medicine Approaches During Early-Phase Clinical Research Room 156ABC #235: The Adventures of Patient Experience in Drug Development Room 252AB #238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer? Room 204AB #239: Generic Drug Town Hall Room 205AB #240: Biosimilars: Demonstrating Structural and Functional Similarity Room 253C #241: Time-to-Event Analysis in Clinical Trials Room 256 #242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date Room 153ABC #243: Global Perspectives on Patient Engagement Room 210AB

11:30am EDT

Luncheon Service Exhibit Hall

12:00pm EDT

#244: Yes, No, Maybe: Sharing Health and Other Data for Research - Enthusiasm and Concern from the Patient Community E and E Exhibit Hall DIA Community Luncheon Ballroom Lobby 3

12:10pm EDT

#245: IQVIA Innovation Theater: Real World Evidence to Enhance Drug Development Theater 1 Exhibit Hall #246: AMPLEXOR Innovation Theater: How Regulatory Information Will Become Part of Your Company Big Data Architecture Theater 2 Exhibit Hall

1:10pm EDT

#247: BioClinica Innovation Theater: Transformational Trends in Investigator Site Payments 2018 Theater 1 Exhibit Hall #248: Veeva Systems Innovation Theater: Tufts Research - Strategies from Data Management Leaders to Speed Clinical Trials Theater 2 Exhibit Hall

1:15pm EDT

#249: Global Evolution in Regulatory Science and Medicine: Novel Modalities and Intersection with Rare Disease Development E and E Exhibit Hall

1:30pm EDT

#250: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials Content Hub NE Lobby

2:00pm EDT

#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations Room 208 #260: Optimizing Clinical Development With Adaptive Trial Designs Room 156ABC #267: Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care Room 252AB #269A: DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars Community Zone NE Lobby #251: Risk Management: New Directions Room 253AB #252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection Room 257AB #253: Digitizing a Patient-Focused Clinical Trial Experience Room 258AB #254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go Room 258C #256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries Room 210C #257: Globalizing and Regionalizing Medical Information Contact Centers Room 209 #258: Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Room 151AB #259: Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask Room 254AB #261: Project Management Throwdown: How Not to Get Chopped Room 153ABC #262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan Room 205C #263: Navigating the Regulatory Landscape of Drug-Device Combination Products Room 204AB #264: Global Development Using Expedited Pathways in Established and Emerging Markets Room 206AB #265: ICH M9 BCS-Based Biowaivers Room 253C #266: User-Friendly Tools for Study Planning and Analysis Room 256 #268: Future of PharmaTech Room 210AB

2:15pm EDT

#269B: Avoiding Rejection on your "First Date" with EMA Policy 0070 E and E Exhibit Hall

3:00pm EDT

Refreshment Break Exhibit Hall

3:15pm EDT

#270: DIA Medical Writing Community Round Table Discussion: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications Community Zone NE Lobby #271: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management - New Directions Community Zone NE Lobby

3:30pm EDT

Annual Meeting of Members DIA Booth #1519 Exh Hall #273: DIA Insights: Latest Global Healthcare Coverage and How to Get Published Content Hub NE Lobby #272: LinkedIn Profile Exchange Review E and E Exhibit Hall

3:40pm EDT

#274: WIRB-Copernicus IRB Group Innovation Theater: Clinical Research Sites: Your Competitive Battleground for Study Success Theater 1 Exhibit Hall #275: Veeva Systems Innovation Theater: Simplifying Variation Management Theater 2 Exhibit Hall

4:15pm EDT

#284: Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials Room 151AB #288: Is It Time to Change the Content and Format of Labeling? Room 205AB #293: Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management Room 257AB #294: Sustainable Healthcare Funding Room 258AB #276: Patient Engagement in Pharmacovigilance Room 253AB #277: Pharmacovigilance: No Longer Going it Alone Room 253C #278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring Room 252AB #279: Redefining the Site Investigator's Experience Room 153ABC #280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers Room 254AB #281: Future of Endpoints Room 258C #282: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials Room 209 #283: Evolving Roles and Responsibilities for Medical Affairs Professionals Room 210C #285: Gene Therapy: Advances in Translating Technology Room 156ABC #286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How? Room 157AB #287: The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team Room 205C #289: Electronic Submissions Demystified Room 204AB #290: Priority Review Vouchers: Here to Stay and Worth the Effort? Room 206AB #291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes? Room 208 #292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs Room 256

4:30pm EDT

#295: DIA Devices and Diagnostics Community Round Table Discussion: Navigating the Regulatory Landscape of Drug-Device Combination Products Community Zone NE Lobby #296: DIA Medical Writing Community Round Table Discussion: CTD Regulatory Defense Strategies - How Best to Prepare Your Response to Health Authority Queries Community Zone NE Lobby

7:00am EDT

Coffee and Light Refreshments North Lobby Attendee, Speaker, and Exhibitor Registration North Lobby

8:00am EDT

#317: Operationalizing Real World Evidence and Value Room 257AB #319: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone Community Zone NE Lobby #320: DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Community Zone NE Lobby #321: PowerUp: Career Transforming Moments Room 157AB #301: Automation in Pharmacovigilance: Doing More With Less Room 253C #302: Risk Communication and Patient Safety: Recent Learnings and New Approaches Room 253AB #303: Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial Room 258C #304: Data and Quality Approaches to Informing Global Investigative Site Selection Room 258AB #305: Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders Room 254AB #306: phactMI: A Collaborative Approach to Advancing the Practice of Medical Information and Enabling Innovative Customer Solutions Room 210C #307: Maintaining Patient Engagement in the Development of Patient-Reported Outcome (PRO) Measures Room 153ABC #308: How Do Patients and Other Multi-Disciplinary Stakeholders Collaborate to Develop Patient Registries which Accelerate Research? Room 151AB #309: Evolution and Harmonization of First-in-Human Guidelines Room 156ABC #310: Becoming Highly Self-Aware: Leading in the Midst of Ambiguity Room 252AB #311: Harnessing the Power of Data and Analytics to Enhance Quality Room 205C #312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH) Room 206AB #313: Global Rare Disease Town Hall Room 205AB #314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Room 204AB #315: Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes Room 208 #316: Opportunities for Efficient and Innovative Study Designs Room 256 #318: Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice? Room 210AB

9:00am EDT

Coffee Break Exhibit Hall Exhibit Hall Open Exhibit Hall Professional Poster Session 2 Posters Exhibit Hall

9:15am EDT

#322: New Resource from the DIA Interdisciplinary Disclosure Working Group Content Hub NE Lobby

9:30am EDT

#323: Good Things Come in Small Packages: Product Development Strategies for Small Companies E and E Exhibit Hall #324: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Patient Engagement in Pharmacovigilance Community Zone NE Lobby #325: DIA Clinical Data Management Community Round Table Discussion: The Letter and Spirit of Risk-Based Monitoring - How to Creatively Implement the RBM and Unlock the Potential of the Team Community Zone NE Lobby

9:45am EDT

#326: ArisGlobal Innovation Theater: A Regulatory Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory Theater 1 Exhibit Hall #327: SAS Institute, JMP Division Innovation Theater: RECIST Criteria and Their Impact on Safety and Efficacy Reporting in Oncology Studies Theater 2 Exhibit Hall

10:00am EDT

#328: Getting the Questions Right Content Hub NE Lobby

10:30am EDT

#333: Streamlining Vendor Reconciliation Room 209 #337: Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally Room 156ABC #329: Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date? Room 253AB #330: Artificial Intelligence: Robots Taking Over Clinical Research Room 253C #331: Rebuilding or Building a Research Site in the Year 2020 Room 254AB #332: Clinical Data: Let’s Get to the Source and Streamline it to the End Room 208 #335: Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care Room 257AB #336: Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement Room 153ABC #338: You've Got Data #now what? Room 157AB #339: Determining Data Integrity: Decoding the Impact of Inspectional Observations Room 258AB #340: Harmonization Beyond ICH Room 206AB #341: New FDA Draft Guidance on Part 11 in Clinical Investigations Room 204AB #342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How Room 205C #343: Innovative Visualization Approaches Room 256 #344: Biosimilar Interchangeability: A Global Perspective Room 205AB #334: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program Room 210C #345: Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally Room 252AB #346: Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care Room 210AB

11:30am EDT

Luncheon Service Exhibit Hall

12:00pm EDT

#348: Making Better Portfolio Prioritization Decisions Content Hub NE Lobby #347: Just the Right Tool: ICH E6 (R2) Compliance Tools for Small to Mid-Size Companies E and E Exhibit Hall

12:10pm EDT

#349: ZS Associates Innovation Theater: Building an RWE Bridge from Population Health to Personalized Medicine Theater 1 Exhibit Hall #350: Salesforce Innovation Theater: Accelerate R&D Innovation with Salesforce for Life Sciences Theater 2 Exhibit Hall

12:45pm EDT

#351: Moving Forward with the EU Vigil: The Patient Contact in Pharmacovigilance Content Hub NE Lobby

1:00pm EDT

#352: DIA Clinical Pharmacology Community Round Table Discussion: Evolution and Harmonization of First-in-Human Guidelines Community Zone NE Lobby #353: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Automation in Pharmacovigilance - Doing More With Less Community Zone NE Lobby

1:10pm EDT

#355: PAREXEL International Innovation Theater: The Application of Mobile Health Across the Clinical Development Spectrum: 5 Critical Insights Theater 2 Exhibit Hall #354: IQVIA Innovation Theater: The Digital Future is Now Theater 1 Exhibit Hall

1:15pm EDT

#356: The Worst Co-Worker on the Block E and E Exhibit Hall

1:30pm EDT

#357: Difficult Conversations Content Hub NE Lobby

2:00pm EDT

#361: A New Way of Authoring and Reviewing Documents for Clinical Development Room 258C #362: Do the Evolution: The Future Role of Clinical Data Management Room 209 #372: AdPromo: Assessing Risk in the Current Regulatory Environment Room 206AB #358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations? Room 253AB #359: IMEDS: A Collaboration Based on the FDA's Sentinel Initiative Room 253C #360: Implementation of eConsent and Other Digital Clinical Trial Innovations Room 258AB #363: Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions Room 157AB #364: Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels Room 210C #365: Engaging the Rare Disease Community to Design Clinical Trials Room 151AB #366: Gene Therapy Clinical Trials: Current Challenges Room 156ABC #367: Real Life Strategies for Collaborative Stakeholder Management Room 252AB #368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling Room 153ABC #369: Virtual Audits: Do They Achieve the Objective? Room 257AB #370: Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials Room 204AB #371: What's New in Health Canada: Updates and New Endeavors Room 205C #373: PMDA Town Hall Room 205AB #374: Modernization and Harmonization of Inspectional Approaches Room 208 #375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints Room 256 #376: Courageous Hiring Room 254AB

2:15pm EDT

#377: First-In-Human Studies: An Examination of the Evolving Regulatory and Clinical Practices to Ensure Subject Safety Content Hub NE Lobby

3:00pm EDT

#378: DIA Devices and Diagnostics Community Round Table Discussion: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Community Zone NE Lobby #379: DIA Clinical Trial Disclosure and DIA Medical Communication Communities' Round Table Discussion: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program Community Zone NE Lobby Refreshment Break Exhibit Hall

3:15pm EDT

#380: Use of New Data Sources and Evidence Types for Regulatory Decision Making in Drug Development E and E Exhibit Hall

3:25pm EDT

#380B: Tata Consulting Services Innovation Theater: TCS' Life Sciences Platforms: Disrupt Clinical Research in a Digital World! Theater 2 Exhibit Hall

3:30pm EDT

#381: Project Management’s Role in Developing and Securing Governance Approval of a Drug Development Program Strategy Content Hub NE Lobby

4:00pm EDT

#394: Update on BREXIT Room 205AB #398: The Impact of Cell and Gene Therapy on the Payer System Room 204AB #382: Artificial Intelligence: A Disruptive Journey for Pharmacovigilance Room 253AB #383: Safe Use and Prescribing of Opioid Medications: An In-Depth Look at the Strategies and Their Evaluation Room 253C #384: Innovations in Managing Global Clinical Supplies Room 258AB #385: Does Sourcing Strategy Matter? Executives Debate the Influence of Outsourcing Model on Clinical Trial Execution Room 258C #386: Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred? Room 257AB #387: Evolving CDISC Standards and Technologies Room 208 #388: Using Patient-Centric Outcomes to Engage Patients in Shared Treatment Decision Making Room 210C #389: Patient Observation Versus Patient Engagement: Optimizing Development Room 151AB #390: Special Population Study Challenges Room 156ABC #391: How to De-Risk Alliances for Success Room 209 #392: FUNdamentals of Project Management Room 153ABC #393: Think Like a Regulator: Evaluating Trial Integrity Room 252AB #395: PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities Room 205C #396: Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence Room 254AB #397: Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making Room 256

8:00am EDT

#401: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management: Artificial Intelligence - A Disruptive Journey for Pharmacovigilance Community Zone NE Lobby #402: DIA Patient Engagement Community Round Table Discussion: Addressing the Elephant in the Room - A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement Community Zone NE Lobby Coffee and Light Refreshments North Lobby Attendee and Speaker Registration North Lobby

8:30am EDT

#403: General Data Protection Regulation (GDPR): Impact, Self-Assessment, and Practical Solutions for Compliance Content Hub NE Lobby

9:00am EDT

#408: Innovative Funding Models for Novel Therapeutics Room 206AB #404: Biologics and Biosimilars: Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance Room 204AB #405: Putting Patient Experience First Room 205AB #406: Improving Efficiency and Effectiveness in Data Management of Pediatric, Rare Disease, and Oncology Trials Room 205C #407: Beyond Adult Patients, Untapped Advisors in Clinical Development: Adolescents, Parents, Siblings, and Spouses Room 209 #409: Emerging Best Practices and Challenges in Strategic Drug Development and Design Decision Making Room 256 #410: Assessing Your Clinical Quality Management System: An In-Depth Look at TransCelerate’s Assessment Tool Room 252AB #411: Regulatory and Industry Perspectives on the Common Protocol Template Room 253C #412: Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability Room 257AB #413: The Correlation Between Patient-Reported Outcomes and Clinician-Reported Outcomes Room 254AB #414: Unmet Medical Need: What Did We Create Together and Where to Take It? Room 208 #415: EMA/FDA Question Time Room 210AB

10:30am EDT

Coffee Break North Lobby

10:45am EDT

#416: FDA Town Hall Room 210AB